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Audit Quality Assurance Support - Senior Associate

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Associate Principal Engineer

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Highly-motivated employee with desire to take on new challenges. Strong worth ethic, adaptability and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.Looking forward to understand the changes and ensure a state-of-the-art environment being cohesive to basics and determination.

Proficient in current APAC regulations, standards and best practices. Analytical and detail-oriented professional focused on making sure products meet all relevant domestic and international regulatory requirements. Methodical and objective with good judgment and sound critical thinking and problem-solving abilities.

Experienced administrative professional knowledgeable about registrations, audits, inspections and other industry regulatory proceedings. Special skill in managing complex documentation, reports and data for regulatory reporting and compliance. Exceptional public relations skills.

Bringing over 14 years of experience in the medical device industry, this biomedical engineer possesses a strong background in post and premarket regulatory affairs. Demonstrating motivation, efficiency, and exceptional organizational skills, this individual excels in navigating FDA guidance and adverse events, such as IDE, 510(k), PMA, Pre-Subs, De Novo, CAPA, and NCs. Leveraging advanced problem-solving abilities and extensive experience, this candidate is adept at overcoming challenges and adapting to shifting day-to-day priorities.

Accomplished professional with extensive expertise in medical devices, process improvement, and quality assurance. Demonstrates a strong command of regulatory affairs and pharmacovigilance, ensuring compliance with ISO 9001 and ISO 13485 standards. Skilled in effective delegating, mentoring, and coaching, fostering team development and operational excellence. Proficient in contract negotiations, driving successful outcomes for stakeholders. Committed to advancing career within the healthcare industry by leveraging core competencies to enhance organisational performance.

Ajeng Tiara Damiarsih

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SPV Business Support & Regulatory Affairs

Pharmacist

Regulatory Affairs & Business Development Officer

Pharmacist

Intern

Intern

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Pharmacist Profession - undefined

Bachelor of Pharmacy - undefined

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SPV Business Support & Regulatory Affairs

Pharmacist

Pharmacist

Regulatory Affairs & Business Development Officer

Intern

Intern

Pharmacist Profession - undefined

Bachelor of Pharmacy - undefined

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